REFLEx Study (ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance

NCT00146822 | Completed Phase 4

• 1 other identifier: CR-CA-022504-L
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The REFLEx Study will evaluate if ENDOTAK RELIANCE G defibrillation leads with GORE ePTFE-covered coils are as good as or better than other comparative commercially available defibrillation leads with respect to electrical performance and termination efficacy in spontaneous tachyarrhythmic episodes.

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (2)

• Lead electrical properties

• First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation

Secondary Outcomes (4)

• Lead handling characteristics

• Lead migration/dislodgment rates

• Characterize the current ICD/CRT-D population

• Effects of ischemia and revascularization and previous lead extraction on the lead's electrical performance

Interventions

ENDOTAK RELIANCE G lead DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet current ICD or CRT-D indications
• Patients who are going to be implanted with one of the aforementioned ICD or CRT-D devices
• Patients who are going to be implanted with active-fixation, dual-coil, endocardial defibrillation leads with compatible connectors (i.e., ENDOTAK RELIANCE G or study-comparative ICD leads)
• Patients who sign and date a Patient Informed Consent form prior to device implant
• Patients who remain in the clinical care of the enrolling physician in approved centers
• Patients who are at least 18 years old

You may not qualify if:

• Patients who have a preexisting transvenous lead system that is not completely explanted
• Patients who are hypersensitive to a single dose of approximately 1.0 mg of dexamethasone acetate
• Patients who are expected to receive a heart transplant during the duration of the study
• Patients whose estimated life expectancy is less than 12 months due to other medical conditions
• Patients who currently have or who are likely to receive a tricuspid valve prosthesis
• Patients who are likely to have an open-chest surgery in the next three months
• Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the REFLEx study.
• Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
• Patients who are pregnant

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Randolph Cooper, MD

  Wake Heart Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: February 1, 2004
• Study Completion: March 1, 2006
• Last Updated: February 6, 2017

Record last verified: 2017-02